VitiligoPhase 1/2ViticellNCT01511965
Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo
A Phase 1/2 study testing autologous (cellular therapy) in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- autologous (cellular therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients at least 18 years
- Subjects with a stable vitiligo (no new injury or lack of expansion of existing lesions in the last 12 months), with at least two vitiligo lesions of at least 10 cm2 located in the same anatomical location, and requiring treatment with UVB phototherapy.
- Topic with vitiligo
- Subjects who agreed to have a blood research with Human immunodeficiency virus (HIV), Human T-lymphotropic virus - 1 (HTLV-1), hepatitis B, hepatitis C, and human Chorionic Gonadotropinfor (hCG) women.
- For women of childbearing age, the use of effective contraception (birth control pills or Intrauterine Device (IUD)) for the duration of the study
- Topics able to participate and to respect it.
- Topics affiliated to social security.
- Topics that have signed a written informed consent before the start of the study.
Who cannot join
- Pregnant or nursing women.
- Subjects with a history of keloid scarring.
- Subjects with a history of melanoma.
- Subjects with a photodermatitis.
- Topics taking photosensitizing treatment.
- Subjects who received treatment for vitiligo in the 4 weeks before enrollment.
- Subjects with HIV testing, hepatitis B or hepatitis C positive.
- Major Topics protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Currently the standard treatment for vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half of patients. The applications of autologous epidermal cells in the liquid phase is a promising new therapeutic approach of vitiligo.
The main goal of this study is to compare prospectively the repigmentation of vitiligo lesions induced by application of autologous epidermal cells in liquid phase associated with light therapy and light therapy alone.
Read more
Study's secondary goals: compare the applications of epidermal cells to phototherapy alone and phototherapy, in respect of:
- Obtain a repigmentation> 70% (threshold considered aesthetically relevant)
- The occurrence of adverse events
- Patient satisfaction regarding the efficacy and safety of treatment
Read the detailed description
MAIN CRITERIA
- Rates of repigmentation of the vitiligo lesions to 12 months
- The lesions of the layers defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a computer.
- Digital photos is taken in order to illustrate the quantitative results above.
SECONDARY CRITERIA
- Repigmentation> 70% of the vitiligo lesions at 12 months
- Rates of repigmentation of the vitiligo lesions at 12 months
- Side effects: the frequency, severity and time of occurrence will be reported for each treatment. Side effects are classified into grades according to World Health Organization (WHO) criteria.
- Patient satisfaction of the effectiveness and tolerance will be studied using visual analogue scales graded from 0 to 10.
- Conditions
- Vitiligo
- Being tested
- autologous (cellular therapy)
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous (cellular therapy)Other
The skin sample, the preparation and implementation of the epidermal cells, are conducted on one day. A review of selected lesions is performed and a photograph. Second, are performed successively in a single day the collection of thin skin, preparing the cell suspension, a desepidermisation laser Erbium: YAG lesions of vitiligo to be grafted, and applicated.
| Study group | Role | What they receive |
|---|---|---|
| traitement A | Other | Lesion 1= graft and lesion 2 = UltraViolet B Receives: Other: autologous (cellular therapy) |
| traitement B | Other | Lesion 1 = UltraViolet B and lesion 2 = graft Receives: Other: autologous (cellular therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of repigmentation of vitiligo lesion to 12 months
The lesions defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a PC computer. Digital photos will be taken in order to illustrate the quantitative results above.
Measured: 12 months
Secondary outcomes (3)
Repigmentation> 70% of vitiligo lesion at 6 months
Measured: 6 months
Side effects
the frequency, severity and time of occurrence of side effects will be reported for each treatment. Side effects are classified into grades according to WHO criteria.
Measured: 12 months
Patient satisfaction
Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Bahadoran, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511965
- Sponsor's protocol ID
- 06-API-01
- Acronym
- Viticell
- Status last verified
- Jan 2014
- First submitted
- 2 Jan 2012
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT01511965
- Acronym / sponsor ID
- Viticell / 06-API-01
- Conditions
- Vitiligo
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Currently the standard treatment for vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half of patients. The applications of autologous epidermal cells in the liquid phase is a promising new therapeutic approach of vitiligo.
The main goal of this study is to compare prospectively the repigmentation of vitiligo lesions induced by application of autologous epidermal cells in liquid phase associated with light therapy and light therapy alone.
Study's secondary goals: compare the applications of epidermal cells to phototherapy alone and phototherapy, in respect of:
- Obtain a repigmentation> 70% (threshold considered aesthetically relevant)
- The occurrence of adverse events
- Patient satisfaction regarding the efficacy and safety of treatment
Detailed description
MAIN CRITERIA
- Rates of repigmentation of the vitiligo lesions to 12 months
- The lesions of the layers defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a computer.
- Digital photos is taken in order to illustrate the quantitative results above.
SECONDARY CRITERIA
- Repigmentation> 70% of the vitiligo lesions at 12 months
- Rates of repigmentation of the vitiligo lesions at 12 months
- Side effects: the frequency, severity and time of occurrence will be reported for each treatment. Side effects are classified into grades according to World Health Organization (WHO) criteria.
- Patient satisfaction of the effectiveness and tolerance will be studied using visual analogue scales graded from 0 to 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traitement A | Other | Other: autologous (cellular therapy)Lesion 1= graft and lesion 2 = UltraViolet B |
| traitement B | Other | Other: autologous (cellular therapy)Lesion 1 = UltraViolet B and lesion 2 = graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Elderly patients at least 18 years
- Subjects with a stable vitiligo (no new injury or lack of expansion of existing lesions in the last 12 months), with at least two vitiligo lesions of at least 10 cm2 located in the same anatomical location, and requiring treatment with UVB phototherapy.
- Topic with vitiligo
- Subjects who agreed to have a blood research with Human immunodeficiency virus (HIV), Human T-lymphotropic virus - 1 (HTLV-1), hepatitis B, hepatitis C, and human Chorionic Gonadotropinfor (hCG) women.
- For women of childbearing age, the use of effective contraception (birth control pills or Intrauterine Device (IUD)) for the duration of the study
Key exclusion criteria (8 listed)
- Pregnant or nursing women.
- Subjects with a history of keloid scarring.
- Subjects with a history of melanoma.
- Subjects with a photodermatitis.
- Topics taking photosensitizing treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous (cellular therapy)The skin sample, the preparation and implementation of the epidermal cells, are conducted on one day. A review of selected lesions is performed and a photograph. Second, are performed successively in a single day the collection of thin skin, preparing the cell suspension, a desepidermisation laser Erbium: YAG lesions of vitiligo to be grafted, and applicated. | Other | traitement A, traitement B |
Primary outcome
Rate of repigmentation of vitiligo lesion to 12 months
Time frame: 12 months
The lesions defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a PC computer. Digital photos will be taken in order to illustrate the quantitative results above.
3 secondary outcomes
Repigmentation> 70% of vitiligo lesion at 6 months
Time frame: 6 months
Side effects
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Bahadoran, PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous (cellular therapy) in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of repigmentation of vitiligo lesion to 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.